UniQure Investors Face Lead‑Plaintiff Deadline in Securities Fraud Case
The dispute over FDA acceptance of external controls could shape uniQure’s approval timeline.
Overview
- Investor law firms, which set Monday as the cutoff, are urging QURE shareholders from the 2025 window to seek lead‑plaintiff status.
- Complaints say uniQure misled investors by suggesting its Huntington’s Pivotal Study had full FDA backing even though it relied on ENROLL‑HD, a historical patient dataset used as an external control.
- Filings also allege the company downplayed the chance it would need extra studies, which would push back its planned Biologics License Application.
- The suits invoke Sections 10(b) and 20(a) and SEC Rule 10b‑5, and cover trades from September 24, 2025 through October 31, 2025.
- No class has been certified, so investors are not represented unless they retain counsel, and the lead plaintiff, once chosen, will direct the case and pick the legal team.